Patent rights battles escalate as debate over drug costs and access drags on

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Intellectual property claims under microscope amid arguments over R&D policy and investment.

Consumer advocates continue to push for initiatives to reduce drug prices by revising or reducing patent protection, as seen in the recent campaign to implement ‘entry fees’ for drugs developed with federal government support. At the same time, governments around the world are advancing a draft agreement on a waiver of intellectual property (IP) protections for COVID-19 vaccines. Disagreement over these and related issues has placed intellectual property claims at the center of debates over biopharmaceutical R&D policy and funding, especially as congressional leaders fail to set price limits. Americans of new therapies for COVID-19, cancer and other serious conditions.

These issues have recently drawn attention as reformers have renewed calls for the National Institutes of Health (NIH) to seize patent rights to the drugs they help develop, a popular strategy for activists seeking wider access to valuable drugs that has long been rejected by government officials as well as manufacturers and academic researchers. Now the battle has grabbed headlines as a group of nonprofits have asked Health and Human Services (HHS) Secretary Xavier Becerra to seize the patent rights to six important therapies. for cancer, COVID-19, HIV, hepatitis C, insulin and asthma that reviews are too expensive for patients to benefit from.1 A primary target is patents on Pfizer’s prostate cancer drug, Xtandi, which reformers and some members of Congress have identified as particularly expensive.2

The Biotechnology Innovation Organization (BIO) responded by stressing how “strong and predictable” patent protections have been essential for the rapid development of new vaccines and treatments for COVID and that dismantling the current intellectual property system will weaken the response to the next pandemic. Similar arguments were made by a coalition of nearly 100 academics, R&D organizations and intellectual property experts, who called on Becerra to reject any seizure of patent rights. They pointed out that exercising “entry” rights jeopardizes agreements between commercial companies and universities that develop important new treatments with the support of federal research funds.3

Advancing the Global Waiver

In addition to challenging biopharmaceutical patent protections in their countries, international public health and consumer organizations have urged the World Trade Organization (WTO) to revise intellectual property policy governing COVID-19 vaccines and therapies to to facilitate wider production and access worldwide. Now, after two years of discussions, key members of the Council for Trade-Related Aspects of Intellectual Property Rights (TRIPS) announced an agreement in mid-March on a possible intellectual property waiver for these vaccines. This initial proposal was supported by the United States, European Union, India and South Africa and now calls for broader support from the WTO as well as industry.4

The compromise, however, aroused objections from all quarters. Public health groups have said the proposal does not go far enough in applying only to vaccines, not diagnostics and antivirals and other much-needed treatments. They want “bolder steps” to extend reforms beyond patents to include trade secrets and respond to broader WTO efforts to secure compulsory licensing.

In turn, biotech and pharmaceutical companies predicted that such a deal would dry up investment in biomedical R&D, especially in the smaller companies that have been behind much of the R&D related to the fight against the pandemic. BIO criticized the proposal as a first step towards dismantling patent rights.5 Similarly, the International Council of Biotechnology Associations (ICBA) said the intellectual property waiver agreement would have a “chilling impact” on investment in smaller companies, where intellectual property is particularly important to encourage research. leading to new breakthroughs.6

The strong objections from all sides, some patent experts have observed, may indicate that the agreement has likely struck a reasonable balance between the opposing parties. The WTO hailed the plan as a “significant breakthrough”, while acknowledging that many more months of work would be needed to get the agreement of all 164 WTO members. This delay supports the most telling criticism that such a patent waiver comes too late in the COVID-19 pandemic to have much impact, as manufacturers have already produced hundreds of millions of vaccine doses and taken action. to expand global distribution. However, this type of agreement could set a precedent for future global health emergencies, and it could be extended to therapies and diagnostics in six months.

The references

  1. https://makemedsaffordable.org/becerra-letter/
  2. https://defazio.house.gov/media-center/press-releases/defazio-doggett-lead-members-in-urging-hhs-to-lower-cost-of-prostate
  3. https://bayhdolecoalition.org/wp-content/uploads/2022/03/Bayh-Dole-Coalition-letter-to-HHS-on-Xtandi-march-in-petition-March-2022.pdf
  4. https://www.wto.org/english/news_e/news22_e/dgno_16mar22_e.htm
  5. https://www.bio.org/press-release/bio-statement-reports-proposed-deal-covid-19-vaccine-ip-rights-waiver
  6. https://internationalbiotech.org/icba-statement-on-leaked-quad-proposal-for-a-covid-19-vaccine-ip-rights-waiver/

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